SSRI Drug for Women’s Libido Likely to Be Rejected by FDA

An experimental women’s libido drug, flibanserin, developed by Sprout Pharmaceuticals, has been advised for rejection by the FDA advisory panel, according to Reuters. Flibanserin is a selective serotonin reuptake inhibitor (SSRI) and was initially tested as an antidepressant. After it was found to be an ineffective antidepressant, flibanserin entered trials as a women’s libido drug. The FDA reviewed the drug’s most recent trial as a women’s libido drug, which did show a statistically significant increase in female satisfying sexual events (SSE’s). However, the FDA said that an increase from .5 to 1 SSE per month does not outweigh side effects of the drug, such as an increase in the risk of fainting or accidental injury. These side effects also seem to worsen when under the influence of alcohol. Other side effects also include nausea, dizziness, and sleepiness. While the official review has not occurred yet, the FDA typically follows the advice of its panel.